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Artelon FlexBand Plus Ref: 41054 & 41057

Class II
Recalling firm
International Life Sciences
Reason for recall
Augmentation devices failed bacterial endotoxin testing.
Distribution pattern
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
State
GA
Status
Ongoing
Recall number
Z-1555-2026
Recall initiated
February 6, 2026
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